Bristol Myers Squibb Receives European Commission Approval for Abecma (Idecabtagene Vicleucel)

Bristol Myers Squibb announced that the European Commission (EC) has granted Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), a first-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Abecma is the first and only CAR T cell therapy approved that is directed to recognize and bind to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.Abecma is delivered via a single infusion with a target dose of 420 x 10 CAR-positive viable T cells within a range of 260 to 500 x 10 CAR-positive viable T cells. Abecma is approved for use in all European Union (EU) member states.*

“The EC approval of Abecma is an important milestone for the treatment of multiple myeloma, and moves us closer to offering a first-in-class, personalized therapy to patients in Europe battling this incurable disease after exhausting prior treatment options with the three standards of care,” said Samit Hirawat, M.D., chief medical officer, Bristol Myers Squibb. “With this third regulatory approval for Abecma worldwide, we are proud to be advancing the science of cell therapy and continuing to bring this first anti-BCMA CAR T cell therapy to patients in need.”

In Europe, nearly 50,000 people are diagnosed with multiple myeloma each year. Despite advances in treatment, multiple myeloma remains an incurable disease, and many patients suffer through periods of remission and relapse. Patients with relapsed and refractory multiple myeloma who have been exposed to all three major drug classes often have poor clinical outcomes and few remaining treatment options.

“In multiple myeloma, when a patient’s cancer is no longer responding to their current treatment regimen or the patient relapses, the disease becomes increasingly difficult to treat,” said Jesus San Miguel, M.D., Ph.D., Medical Director of the Clinica Universidad de Navarra, Navarra, Spain and KarMMa clinical trial investigator. “In the KarMMa trial, treatment with ide-cel proved to elicit deep and durable responses in a significant proportion of patients with triple-class exposed multiple myeloma, including many who were heavily pretreated and had high-risk disease. The approval is important for patients in Europe, as it represents another potential therapeutic option for clinically meaningful outcomes and long-term disease control.”

Bristol Myers Squibb is committed to making Abecma commercially available to patients in the EU. The company is currently focused on several required factors, including treatment center qualification and onboarding, completion of reimbursement procedures and scaling up its manufacturing capacity to meet increasing global demand. The company is also actively pursuing options to expand its manufacturing global supply network to make Abecma available to more patients around the world, including the addition of a European-based manufacturing facility in Leiden, Netherlands. Meanwhile, Bristol Myers Squibb will continue to manufacture Abecma for EU and U.S. patientsat the company’s state-of-the-art cellular immunotherapy manufacturing facility in Summit, New Jersey.

“Multiple myeloma patients who have tried and exhausted multiple rounds of treatment options have been hoping for new and transformative options,” said Brian G.M. Durie, Chairman, International Myeloma Foundation. “The approval of Abecma, an innovative anti-BCMA CAR T cell therapy, is an exciting milestone for patients in the European Union.”

Abecma was granted Conditional Marketing Authorization under the European Medicines Agency PRIME (Priority Medicines) scheme. Conditional Marketing Authorization is granted in the interest of public health where the benefit of immediate availability fulfills a critical unmet need. Conditional Marketing Authorization in the EU is initially valid for one year but can be extended or converted into a full Marketing Authorization after the submission and assessment of additional confirmatory data. For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

Bristol Myers Squibb offers various programs and resources to address the needs of patients and caregivers and help support access to therapies, including Abecma.

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).